MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-07 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903200 390-320 manufactured by Boston Scientific - Marlborough.
[110460756]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(6). Device component code relates to device problem code for the investigation result of coil coating peeled. (b)(4). A stone cone retrieval coil was received for analysis. A visual analysis revealed that the coil on the device was returned tangled. The device opened freely but only closed to the tangled area. The coil was untangled easily. After the device was untangled, the device only opened approximately half way. The blue/green shrink is pulled away from the distal stop. The complaint that the device was damaged was confirmed due to the condition of the returned device. Since the damage occurred during unpacking, the most probable root cause for this event is "handling damage". The complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution. A search of the complaint database revealed that no similar complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
[110460757]
It was reported to boston scientific corporation that a stone cone retrieval coil was to be used in a ureteroscopy procedure performed on (b)(6) 2018. According to the complainant, during unpacking, the device was noticed to be damaged. The procedure was completed with another stone cone. The were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable. This event has been deemed a reportable event based on the investigation results; coil coating peeled/shared/frayed. Please see block for full investigation details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01786 |
| MDR Report Key | 7579996 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-07 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2017-08-10 |
| Date Added to Maude | 2018-06-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2018-06-07 |
| Returned To Mfg | 2018-04-12 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | 0003815163 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-07 |